Avinger has completed enrolling peripheral artery disease (PAD) patients in its CONNECT II clinical trial.
The prospective, multi-center, non-randomized trial that evaluated 100 PAD patients with femoropopliteal CTO lesions was designed to study the safety and efficacy of Ocelot catheter.
Ocleot is an interventional chronic total occlusion crossing catheter which allows physicians to use real-time intravascular imaging technology called optical coherence tomography to see and navigate inside totally blocked arteries in the legs of patients suffering from PAD.
The company said it will present CONNECT II results at the VIVA conference in October 2012, file a 510K with the FDA later this summer, and expects to receive 510K clearance in late 2012.
The company has also requested FDA approval of an additional 125 patients to be enrolled and treated in a continued access cohort in order to ensure that Ocelot is available for use at US CONNECT II sites during the 510K review period.
CONNECT II clinical trial co-principal investigator Matthew Selmon said the results from the trial will have a major impact on how physicians treat patients with severe PAD.
"We are pleased that a request for Continued Access has been submitted," Selmon added.
"It means the Heart Hospital may be able to continue treating patients with Ocelot in order to quickly improve their mobility and return to a healthier quality of life."